Effect of Two Different Doses of Dexmedetomidine Infusion in Morbidly Obese Patients

The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study

Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Anesthesia; Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine 0.6; Drug: Dexmedetomidine 0.3; Drug: Saline

Detailed Description

Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.

The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
• Aged 18-50 years.
• Scheduled for abdominal surgery.

Exclusion Criteria:

• Patients with Forced expiratory volume1/forced vital capacity<7.
• Uncontrolled cardiac, respiratory, hepatic or renal diseases.
• Allergy to the study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine 0.6 group; patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.	Drug: Dexmedetomidine 0.6; Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.6 μg/kg/hr for one hour.
Active Comparator: Dexmedetomidine 0.3group; patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.	Drug: Dexmedetomidine 0.3; Patients received a bolus dose of 1μg/kg Dexmedetomidine, 15 minutes after endotracheal intubation over 10 minutes followed by infusion of 0.3 μg/kg/hr for one hour.
Placebo Comparator: Control group; Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.	Drug: Saline; Patients received over 10 minutes comparable volume of normal saline (0.9%) 15 min after endotracheal intubation followed by infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative oxygenation	Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Lung compliance	Dynamic lung compliance=tidal volume/ (peak airway pressure- Positive end-expiratory pressure).	Intraoperative
Post-operative pain	Assessment of post-operative pain by The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme	24 hour postoperatively
Dead space (dead space to tidal volume)	Physiological dead space was calculated by Hardman and Aitkenhead equation: (dead space to tidal volume) = 1.14(PaCO2 -EtCO2)/PaCO2- 0.005 dead space (%) = dead space by end of infusion - dead space at the base line / dead space by the end of drug infusion %	Intraoperative
Quality of recovery score	The Quality of recovery score scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery	24 hours Postoperatively
Time to first rescue analgesia	Time to first rescue analgesia as morphine consumption was recorded	24 hours Postoperatively
Static lung compliance	Static lung compliance =tidal volume /(plateau pressure - Positive end-expiratory pressure).	Intraoperative
Lung compliance	compliance = dynamic compliance at the end of the drug infusion - baseline dynamic compliance.	24 hours
Plateau pressure	Plateau pressure was calculated by increasing end inspiratory pause to 30-40%.	Intraoperative

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: July 2, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Estimated): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 33360/09/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No